Recruiting

Antimicrobial Stewardship

Sponsor:

University of British Columbia

Code:

NCT04388293

Conditions

Multi-Drug Resistant Organisms

Late-Onset Sepsis, Neonatal

Antimicrobial Resistance

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Exposure of interest

Study Details

Brief summary:

There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

Conditions

Multi-Drug Resistant Organisms

Late-Onset Sepsis, Neonatal

Antimicrobial Resistance

Study ID

NCT04388293

Start date

Jan 1, 2020

Status verified date

Dec, 2021

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada.

Exclusion Criteria:

  • infants with major congenital anomalies

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Exposure of interest

Very Low Birth Weight infants admitted to tertiary NICUs in Canada.

Primary outcome measure

  • Days of therapy/1000 patient-day of each category of antimicrobial consumption [ Time Frame: 2020-2025 ]
  • Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay [ Time Frame: 2020-2025 ]

Central Contacts and Locations

Central contacts

Joseph Ting, Associate Prof

+1(780)248-5408joseph.ting@ualberta.ca

Locations

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Joseph Ting, MD, MPH

+1(780)248-5408joseph.ting@ualberta.ca

More Information

Sponsor

University of British Columbia

Last update posted

Dec 28, 2021

Last verified

Dec, 2021

Keywords

  • Antimicrobial Stewardship
  • Prematurity
  • Neonate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-12-28.